更新于 3月17日

Varian IO Production Operator

5000-6000元
  • 杭州临安区
  • 5-10年
  • 高中
  • 全职
  • 招1人

职位描述

工艺操作无菌医疗器械医疗器械生产质量管理规范医疗设备/器械
Ø 角色概述
负责三类医疗器械产品的生产、组装、包装全流程操作,熟悉并严格遵循 GMP 相关法规要求,确保生产过程合规、高效、质量可控。
Ø 主要工作职责
1. 在生产主管 / 经理的管理下,保障生产车间质量合规与EHS 合规。
2. 执行并跟进生产计划,确保个人产出满足质量标准与生产效率要求。
3. 熟练掌握产品全流程操作技能,包括物料准备、清洁、焊接、过程控制、组装、包装及返工,并按作业指导书完成资质认证。
4. 按计划完成日常生产操作,确保产品质量与一次合格率符合标准。
5. 规范完成生产记录,确保所有记录满足GMP要求。
6. 负责生产区域的清洁与维护,确保车间环境符合GMP要求。
7. 负责洁净区日常环境监测、清洁与维护,包括洁净区、更衣区、清洁间、清洗间、走廊等区域。
8. 严格遵守 EHS 相关规定,发生任何安全事故或未遂事件立即上报。
9. 每日上报生产产出,整理生产 KPI 相关数据;下班前检查并关闭车间水、电、气及门窗。
10. 参与车间内不合格事件 / 纠正预防措施(IR/CAPA)的调查,生产过程中出现异常立即上报。
11. 负责生产记录、作业指导书(WI)及相关标准操作规程(SOP)的维护与更新。
12. 必要时配合仓库及其他生产相关团队开展工作。
13. 完成上级安排的其他工作任务。
Ø 任职资格
1. 经验:5 年及以上三类医疗器械相关生产工作经验,具有介入产品生产经验或组装、锡焊经验更佳。
2. 学历:高中及以上学历,大专及以上优先。
3. 语言:具备良好的中文沟通与读写能力;具备基础英语能力者优先。
4. 培训:能够及时完成岗位相关培训并通过考核。
5. 技能:熟练使用 Office 办公软件(Excel、PPT、Word),有 ERP 系统(如 SAP)使用经验优先。
6. 素养:熟悉GMP及医疗器械生产相关法规,工作严谨细致,责任心强,具备良好的合规意识与团队协作能力。

工作地点

临安区Varian-杭州艾力康医药科技有限公司

认证资质

营业执照信息

职位发布者

胡明/瓦里安医疗

刚刚活跃
立即沟通
公司Logo瓦里安医疗
美国瓦里安医疗系统—全球放疗先驱 Varian Medical Systems, Inc., of Palo Alto, California, is the world's leading supplier of radiotherapy equipment and software for treating cancer. The company is also a premier supplier of components including X-ray tubes and digital image detectors for medical, scientific, and industrial imaging. Varian Medical Systems employs approximately 3,600 people who are located at manufacturing sites in North America, Europe, China and in its 56 sales and support offices around the world. Building on 25 years of sales and service experience in China, Varian is establishing a wholly foreign-owned enterprise(WFOE) in Beijing. Varian is constructing a new state of the art manufacturing facility in BDA, a well-established industrial zone located in Beijing. The new plant will create medical linear accelerators for the Chinese market and for global export, Varian's efforts will increase the availability of high quality radiotherapy equipment to Chinese clinicians and patients, improving the quality of cancer care in China and helping save lives. More information about Varian business and its products can be found online at the company's Web site www.varian.com. We are looking for energetic, innovative and experienced professionals in China, and offer a competitive salary, outstanding benefit package and the professional advantages of an environment that supports your development and recognizes your achievements. If you are looking for a career in a challenging, innovative and fast paced environment, Varian should be the place for you.
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